Status:
UNKNOWN
Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema
Lead Sponsor:
Yeungnam University College of Medicine
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the investigator's study is to evaluate the efficacy and safety profile of the pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes with treatment-na...
Detailed Description
Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and monocyte chemotactic pr...
Eligibility Criteria
Inclusion
- Male and females 18 years of age or older
- Written informed consent has been obtained
- Diabetic macular edema with a central macular thickness (CMT) ≥ 300um measured by spectral domain optical coherence tomography.
- Treatment-naïve subjects for diabetic macular edema.
- Documented BCVA of ETDRS letter score of 23 to 73 letters (Snellen equivalent of 20/320 to 20/40) in the study eye.
Exclusion
- Previous panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye
- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for diabetic macular edema
- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study
- Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1
- Elevated intraocular pressure or a history of steroid-induced ocular hypertension
- The presence of other retinopathies, maculopathies, visually significant cataract, vitreomacular traction, peripheral ischemia, history of pars plana vitrectomy
- Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening
- Any history of allergy to povidone iodine
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04448496
Start Date
June 22 2020
End Date
December 31 2021
Last Update
June 26 2020
Active Locations (7)
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1
Dong-A University Hospital
Busan, South Korea
2
Maryknoll Medical Center
Busan, South Korea
3
Gyeongsang National University Changwon Hospital
Changwon, South Korea
4
Yeungnam university hospital
Daegu, South Korea, 42415